The Investigative Site Budget Specialist (ISBS) is responsible for supporting the overall budget development process for site-facing budget templates, which includes working independently with business partners to develop global clinical site budgets, coordination of the multiple activities required to independently manage budget development to support clinical studies from start to close, serving as a key contributor for clinical contracts process improvement and quality initiatives related to the function, providing solutions-based expertise both internally and externally at a global level, and managing business partner interfaces to ensure the business achieves study start-up goals and effective deliverables.

Investigator Budget Build:

• Takes the lead role in development of site budgets for global utilization to ensure actionable, relevant budgets are provided to business partners on time
• Accountable for drafting, reviewing and finalizing the creation of global clinical trial budget templates in accordance with Fair Market Value (FMV) and industry best practices
• Amendment responsibilities as needed as protocol requirements mandate
• Utilizes grant planning/industry cost benchmarking tools, International Classification of Diseases codes (i.e. ICD-9/10) and Current Procedure Terminology (CPT) codes to ensure standardization of budget template format
• Monitors timelines for all clinical studies to ensure global budgets are built within study required timelines for both original and amended protocols and delivers to business partners on time
• Supports business partner requests for ad hoc cost benchmarking analysis and global budget template development

Budget Oversight & Negotiation Support:

• Creates comprehensive parameters and tools for the Contracting Team to use for budget negotiations
• Provides input into and supports global clinical site budgeting process and negotiation
• Updates Master Budget Templates as appropriate in terms of benchmarks and exchange rates and continues to update budget templates to conform with internal budget negotiation parameters and in line with current industry trends
• Updates the Master Investigator Fee Budget Template to align with internal processes and tools such as the new site payment system
• Maintains documentation and database of approvals, including approvals for Master templates

Leadership:

• Serves as a Subject Matter Expert for cost benchmarking and cost benchmarking tools, providing internal training and ongoing support on a global level
• Responsible for oversight of Investigator Budget Analyst staff including workload management, quality of deliverables and escalation of issues to management when needed
• Supports the development and delivery of site budgeting process training and documentation, which includes contributing to the Clinical Contracts team onboarding plan and curriculum
• Identifies training needs, formulates strategies to address training gaps, and conducts training as needed
• Identifies and leads ongoing process improvement initiatives and training sessions related to the global site budget development process (including participating in pivotal initiatives), contributing to quality, systems and process initiatives
• Onboarding, training, and mentoring peers with regard to site budgeting, including training the Clinical Contracts team on budget processes, Client best practice, and negotiation strategy
• Responsible for development of process and acceptable guidelines for approvable budgetary requirements
• Works on problems of diverse scope, as assigned by Manager/Director, where analysis of situations or data requires evaluation of identifiable factors

Collaborative Relationships:

• Works with Clinical Development Operations, Finance, Legal, the Site Contracting Team, Functional Service Providers, and Clinical Research Organizations (CROs) to ensure proper clinical trial budget development, training and dissemination occurs
• Responsible and accountable for leading a meeting with Clinical and Global Site and Study Operations, Finance, Functional Service Providers, and/or CROs for budget delivery and explanation of the Master Template and/or parameters to ensure proper understanding to allow a high level of negotiation
• Collaborates with and supports colleagues with the negotiation of site budgets and ancillary documents
• Collaborates with Clinical and Global Site and Study Operations as needed for clarifications, providing education on the budget development process and rationale for items in the budget template

Knowledge and Experience:

• 8+ years of professional work experience, including 5+ years in a research setting with pharmaceutical industry expertise in clinical contracting, outsourcing or finance is required
• Demonstrates the qualifications needed to train and Quality Control (QC) the work of colleagues
• Demonstrated ability in negotiation, project management, effective communication and relationship management
• Demonstrates a high level of contract/budget and technical competencies across multiple therapeutic areas, which includes a high level of competence in negotiation and contracting/budgeting business standards
• Contract negotiation experience in a scientific setting preferred
• Demonstrated experience in contracts, budgets, clinical site/sponsor relationship and performance related to clinical drug studies preferred

Education:

• Bachelor’s degree or equivalent or relevant and qualifying training/experience

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